Novo Nordisk
Semaglutide reduced risk of CKD progression in phase 3 FLOW trial
Semaglutide delayed progression of CKD in diabetes patients in the phase 3b FLOW study—reducing the risk of death from CKD and major cardiac events by 24%. The trial was stopped in October, almost a year ahead of schedule, because it was clear from an interim analysis that the treatment would succeed.
Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the U.S. and European Union in 2024. The company also plans to present detailed results from FLOW at a scientific conference later this year.
Study takeways:
- The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and CV mortality in people with type 2 diabetes and CKD.
- CKD was defined as eGFR2 ≥50 and ≤75mL/min/1.73 m2 and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g.
- The trial, initiated in 2019, enrolled 3,533 people with type 2 diabetes and CKD, was conducted in 28 countries at around 400 investigator sites.
- The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression as well as CV and kidney death of 24% for people treated with semaglutide 1.0 mg compared with placebo.
- The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and CV mortality. Both CKD and CV components of the primary endpoint contributed to the risk reduction. Further, superiority of semaglutide 1 mg vs. placebo was confirmed for the secondary endpoints.
- In the trial, semaglutide 1.0 mg appeared safe and well-tolerated, in line with previous semaglutide 1.0 mg trials.
Source:
(2024, March 5). Novo Nordisk. Company announcement. Novo Nordisk A/S: Semaglutide 1.0 mg demonstrates 24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease in the FLOW trial. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=167028